Indian generic drug manufacturers consider the Kenyan Anti-counterfeit law a threat and industry players have been lobbying to seek its defeat

NAIROBI (Xinhua) — Kenya’s pending signature of a trade deal with the European Union (EU) could block the importation of generic drugs from India, threatening the lives of a third of 1 million people on life-saving HIV/AIDS drugs.

A panel of health and gender experts appointed by the African Union (AU), who visited Kenya this week to investigate the status of people living with HIV, said the parallel importation of the anti-retroviral (ARVs) drugs could be threatened in Kenya.

The African Commission on Human and People’s Rights, appointed the expert committee to undertake the review visit to Kenya to engage the government and the civil society in talks on the status of people living with HIV.

The experts said apart from the pending signing of the Economic Partnership Agreement (EPA) with the European Commission, the passing of an anti-counterfeit law in Kenya, was likely to block the importation of the generic drugs into Kenya.

“The Committee is concerned by some provisions of the Anti- Counterfeit Act (No.13) of 2008 which could jeopardize access to affordable HIV treatment,” said Agnes Atim, a Ugandan gender expert, who read a statement on behalf of the team.

“The law describes counterfeits as a product that imitates the genuine goods.

“This practice has been a thorny issue to businesses and consumers in Kenya for a long time, ” the government argues.

HIV activists say the anti-counterfeit law could ban the importation of generic drugs, mostly from India, whose pharmaceutical firm, Cipla, has been against the definition of anti-counterfeit legislation, which it says is an agenda by powerful western firms.

“This debate is an agenda of big pharmaceutical companies,” said Christian Garuka, a Rwandan HIV and Human Rights Researcher.

“If Kenya is providing drugs to more people through the generic drugs, the country would not meet the number of people currently being covered by the ARVs from the patented drugs.”

Kenya has been facing a shortage of ARVs for several months. The shortage of ARVs saw the entry into circulation of counterfeit ARVs in the market.

Kenya’s Medical Services Minister Anyang Nyong’o says there is no need for panic about the circulation of counterfeit ARVs, which have been recalled by the state-run Kenya Pharmacy and Poisons Board, which vets drugs for toxicity and efficacy.

“We should not be too alarmed about it.

“Counterfeiters always cash in into the news that there is a shortage.

“The Pharmacy and Poisons Board has tried its best.

“It has deployed the measures to remedy the situation,” Nyongo said on national television.

The entry into the market of the generic drugs manufacturers from India saw the costs plummet from 15,000 U.S. dollars a year to 150 dollars a year per patient.

“Generic drugs manufacturers in Kenya compete well with other manufactured generic drugs from other countries such as India,” Nyong’o said.

“The imported drugs are easy to counterfeit. Counterfeiters are like thieves, they will strike when it is absolutely necessary,” Nyong’o revealed.

Members of the AU rights body said Kenya would be required to explain the steps it would have taken to ensure an expanded access to life-saving drugs for a million strong group of HIV positive patients who are unable to enter the ARVs list.

“The key issue here is access to medicine.

“The ARVs are 95 percent purchased by donors.

“This is a very fragile situation for Kenya should the donors’ pullout.

Kenya’s Public Health and Sanitation Minister Beth Mugo said in March the ministry had received 9 million dollars from the Treasury to purchase the ARVs for some 300,000 people on the life- saving ARVs.

But most of those on the state-funded ARVs are funded under the U.S. President Emergency Fund for AIDS Relief, the Global Fund and the Clinton Initiative.

Indian generic drug manufacturers consider the Kenyan anti-counterfeit law a threat and industry players have been lobbying to seek its defeat.

A section of HIV patients had planned to challenge the law in court on the basis that it denied their right to life by blocking access to affordable life-prolonging medicine.

Kenyan law considers the reproduction-patented drugs as “counterfeiting and privacy infringement of intellectual property rights.”

The World Trade Organisation (WTO) allowed the manufacture of generic drugs under compulsory licensing.

In such cases, a government can allow someone else to produce the patented product or process without consent of the patent owner.

This is contained in the TRIPS – Trade Related Aspects of Intellectual Property Rights – The deal allows generic copies to be produced for domestic markets.

“We feel human rights laws and policy is one way of working to protect the people living with HIV.

“We need to address the issue of resources,” Atim told Xinhua.

Historically, some 1.5 million people are listed as living with HIV, but only 300,000, who make 75 per cent of those already on government donor funded ARVs receive treatment.

Activists say those on treatment could be considered as only 50 per cent.

“The other 50 per cent are waiting to die.

“People’s rights to healthcare should be addressed,” Atim added.

Kenya’s Public Health Ministry says 80 per cent of the people living with HIV would be put on antiretroviral treatment within the next four years.

Analysts fear the pending signing of the EPA would allow Kenya to trade exclusively with EU, to the exclusion of the Indian firms, whose exports of generic drugs could be blocked following the pending signing of the trade deal within the next few weeks.

The tussle for control of the Kenyan drugs market has contributed to the ongoing shortage of ARVs.

In October 2009, the High Court in Kenya stopped a consortium of drug suppliers from availing the ARVs because of a tendering row.

The tender appeals board at the Treasury blocked a consortium of British and German firms from importing the generic drugs after an Indian firm appealed.

Crown Agents of Britain, GTZ of Germany and research group, John Snow, Inc, clinched the tender.

Hetero Drug Limited of India, successfully challenged the tendering process, insisting the rules were violated, forcing the halting of the tendering process.

Kenya first allowed the importation of generic ARVs in 2002 to cut down on the cost of patented ARVs, which cost 850 dollars a year then.

The generic drugs for triple therapies, including AZT, 3TC and nevirapine cost 295 dollars a year.

“The patented drugs are seven to 10 times more expensive.

“The price depends on the drug and the company,” said Garuka.

He said the fact that the generic drugs are cheaper does not mean these drugs are sub-standard.

Five Indian generic drug-manufacturing firms were amongst the first group of firms to apply for licenses to begin the importation of the generic drugs.

Nyong’o said the mistake of the counterfeit drug manufacturers was that they took advantage of the ARV shortage and tried to sell drugs to the Kenya Medical Supplies Agency (KEMSA), the state agency importing drugs, which subjected the drugs to thorough tests before clearing them for distribution, which led to the discovery.

What is it all about?

This blog is a platform to update, share and comment on recent events concerning trade and health (Free Trade Agreements (FTAs), multilateral treaties (TRIPS and its flexibilities), IP laws and policies) as well as the question on how to create an alternative R&D system not based in IP that is guided by health needs and not profits.

If you want to contribute by writing an article, or sharing documents, pictures etc. on this topic you are highly encouraged to do so! This blog depends on your contribution! Please contact us, to get access to the page: